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Cladribine tablets are a cost-effective strategy in high-disease activity relapsing multiple sclerosis patients in Iran

Document Type : Original Article

Authors

1 Department of Pharmacoeconomics and Pharmaceutical Administration, School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran

2 Merck Serono Middle East FZ-Ltd, an affiliate of Merck KGaA, Darmstadt, Germany

3 MS Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran

Abstract

Background: Cladribine tablets are the foremost oral immune-reconstitution therapy for high disease activity relapsing multiple sclerosis (HDA-RMS). We aimed to assess the cost-effectiveness of cladribine tablets compared to natalizumab in patients with HDA-RMS in Iran.
Methods: A 5-year cohort-based Markov model was developed with 11 expanded disability status score (EDSS) health states, including patients with HDA-RMS as on and off-treatment. All costs were identified from the literature and expert opinion and were measured in Iranian Rial rates, changed to the 2020 USD rate and were discounted by 7.2%. Quality adjusted life years (QALY), discounted by 3.5%, and life years gained (LYG) were adopted to measure efficacy. The final results were presented as incremental cost-effectiveness ratio that was compared to a national willingness to pay (WTP) threshold of 1 to 3 gross domestic product (GDP) per capita. Deterministic and probabilistic sensitivity analyses (D/PSA) were employed to evaluate uncertainty.
Results: Cladribine tablets dominated natalizumab and yielded 6,607 USD cost-saving and 0.003 additional QALYs per patient. LYG was comparable. The main cost component was drug acquisition cost in both arms. DSA indicated the sensitivity of the results to the cost discount rates and also the patients’ body weight; while they were less sensitive to the main clinical variables. PSA indicated that cladribine tablets were cost-effective in Iran, with a probability of 57.5% and 58.6% at lower and higher limits of threshold, respectively.
Conclusion: Cladribine tablets yielded higher QALYs and lower costs compared to natalizumab, in patients with HDA-RMS in Iran.

Keywords

References
  1. Yamout B, Sahraian M, Bohlega S, Al-Jumah M, Goueider R, Dahdaleh M, et al. Consensus recommendations for the diagnosis and treatment of multiple sclerosis: 2019 revisions to the MENACTRIMS guidelines. Mult Scler Relat Disord 2020; 37: 101459.
  2. Stenager E. A global perspective on the burden of multiple sclerosis. Lancet Neurol 2019; 18(3): 227-8.
  3. Azami M, YektaKooshali MH, Shohani M, Khorshidi A, Mahmudi L. Epidemiology of multiple sclerosis in Iran: A systematic review and meta-analysis. PLoS One 2019; 14(4): e0214738.
  4. Goldenberg MM. Multiple sclerosis review. P T 2012; 37(3): 175-84.
  5. Taheri S, Sahraian MA, Yousefi N. Cost-effectiveness of alemtuzumab and natalizumab for relapsing-remitting multiple sclerosis treatment in Iran: decision analysis based on an indirect comparison. J Med Econ 2019; 22(1): 71-84.
  6. Burkill S, Montgomery S, Hajiebrahimi M, Hillert J, Olsson T, Bahmanyar S. Mortality trends for multiple sclerosis patients in Sweden from 1968 to 2012. Neurology 2017; 89(6): 555-62.
  7. European Medicines Agency. Mavenclad: Annex I: Summary of Product Characteristics [Online]. [cited 2018]; Available from: URL: https://www.ema.europa.eu/en/documents/product-information/mavenclad-epar-product-information_en.pdf
  8. Hughes R, Brainin M, Gilhus NE. European Handbook of Neurological Management. Oxford, UK: Wiley-Blackwell; 2008.
  9. Ohlmeier C, Gothe H, Haas J, Osowski U, Weinhold C, Blauwitz S, et al. Epidemiology, characteristics and treatment of patients with relapsing remitting multiple sclerosis and incidence of high disease activity: Real world evidence based on German claims data. PLoS One 2020; 15(5): e0231846.
  10. Naci H, Fleurence R, Birt J, Duhig A. Economic burden of multiple sclerosis: A systematic review of the literature. Pharmacoeconomics 2010; 28(5): 363-79.
  11. Wiendl H. Cladribine - an old newcomer for pulsed immune reconstitution in MS. Nat Rev Neurol 2017; 13(10): 573-4.
  12. US Food and Drug Administration. FDA-Approved Drugs: Mavenclad [Online]. [cited 2019 Apr 26]; Available from: URL: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022561
  13. Giovannoni G, Comi G, Cook S, Rammohan K, Rieckmann P, Soelberg SP, et al. A placebo-controlled trial of oral cladribine for relapsing multiple sclerosis. N Engl J Med 2010; 362(5): 416-26.
  14. Giovannoni G, Soelberg SP, Cook S, Rammohan K, Rieckmann P, Comi G, et al. Safety and efficacy of cladribine tablets in patients with relapsing-remitting multiple sclerosis: Results from the randomized extension trial of the CLARITY study. Mult Scler 2018; 24(12): 1594-604.
  15. Khanizadeh H, Izham M, Akmal A. PND12 the costs analysis of multiple sclerosis at different stages in Iran. Value Health 2012; 15(4): A143.
  16. Torabipour A, Asl ZA, Majdinasab N, Ghasemzadeh R, Tabesh H, Arab M. A study on the direct and indirect costs of multiple sclerosis based on expanded disability status scale score in Khuzestan, Iran. Int J Prev Med 2014; 5(9): 1131-8.
  17. Hettle R, Harty G, Wong SL. Cost-effectiveness of cladribine tablets, alemtuzumab, and natalizumab in the treatment of relapsing-remitting multiple sclerosis with high disease activity in England. J Med Econ 2018; 21(7): 676-86.
  18. Michels RE, de FM, Mahajan K, Hengstman GJD, Schiffers KMH, Budhia S, et al. Cost effectiveness of cladribine tablets for the treatment of relapsing-remitting multiple sclerosis in the netherlands. Appl Health Econ Health Policy 2019; 17(6): 857-73.
  19. Robberstad B. Estimation of private and social time preferences for health in northern Tanzania. Soc Sci Med 2005; 61(7): 1597-607.
  20. Abdoli G, Heydari H. An estimation of social discount rate based on hazard rate for Iran and selected countries. Iranian Economic Research 2009; 13(38): 1-29. [In Persian].
  21. Marseille E, Larson B, Kazi DS, Kahn JG, Rosen S. Thresholds for the cost-effectiveness of interventions: alternative approaches. Bull World Health Organ 2015; 93(2): 118-24.
  22. Meyer-Moock S, Feng YS, Maeurer M, Dippel FW, Kohlmann T. Systematic literature review and validity evaluation of the Expanded Disability Status Scale (EDSS) and the Multiple Sclerosis Functional Composite (MSFC) in patients with multiple sclerosis. BMC Neurol 2014; 14: 58.
  23. Patzold T, Schwengelbeck M, Ossege LM, Malin JP, Sindern E. Changes of the MS functional composite and EDSS during and after treatment of relapses with methylprednisolone in patients with multiple sclerosis. Acta Neurol Scand 2002; 105(3): 164-8.
  24. Lambe T, Duarte R, Mahon J, Nevitt S, Greenhalgh J, Boland A, et al. Cladribine tablets for the first-line treatment of relapsing-remitting multiple sclerosis: an evidence review group perspective of a nice single technology appraisal. Pharmacoeconomics 2019; 37(3): 345-57.
  25. Maurer M, Comi G, Freedman MS, Kappos L, Olsson TP, Wolinsky JS, et al. Multiple sclerosis relapses are associated with increased fatigue and reduced health-related quality of life - A post hoc analysis of the TEMSO and TOWER studies. Mult Scler Relat Disord 2016; 7: 33-40.
  26. Behaeein B, Yadolazadeh A, Same H, Etemadi S, Sadegi H, Salehian MH. Relation of anthropometric characteristics in women with different types of ms and comparison with health ones. Scholars Research Library 2011; 2(5): 14-21.
  27. Eskandarieh S, Heydarpour P, Elhami SR, Sahraian MA. Prevalence and incidence of multiple sclerosis in Tehran, Iran. Iran J Public Health 2017; 46(5): 699-704.
  28. Polman CH, O'Connor PW, Havrdova E, Hutchinson M, Kappos L, Miller DH, et al. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med 2006; 354(9): 899-910.
  29. Berardi A, Siddiqui MK, Treharne C, Harty G, Wong SL. Estimating the comparative efficacy of cladribine tablets versus alternative disease modifying treatments in active relapsing-remitting multiple sclerosis: Adjusting for patient characteristics using meta-regression and matching-adjusted indirect treatment comparison approaches. Curr Med Res Opin 2019; 35(8): 1371-8.
  30. Siddiqui MK, Khurana IS, Budhia S, Hettle R, Harty G, Wong SL. Systematic literature review and network meta-analysis of cladribine tablets versus alternative disease-modifying treatments for relapsing-remitting multiple sclerosis. Curr Med Res Opin 2018; 34(8): 1361-71.
  31. Hawton A, Green C. Health utilities for multiple sclerosis. Value Health 2016; 19(4): 460-8.
  32. Orme M, Kerrigan J, Tyas D, Russell N, Nixon R. The effect of disease, functional status, and relapses on the utility of people with multiple sclerosis in the UK. Value Health 2007; 10(1): 54-60.
  33. Acaster S, Perard R, Chauhan D, Lloyd AJ. A forgotten aspect of the NICE reference case: An observational study of the health related quality of life impact on caregivers of people with multiple sclerosis. BMC Health Serv Res 2013; 13: 346.
  34. Boye KS, Matza LS, Walter KN, Van Brunt K, Palsgrove AC, Tynan A. Utilities and disutilities for attributes of injectable treatments for type 2 diabetes. Eur J Health Econ 2011; 12(3): 219-30.
  35. Trogdon JG, Ekwueme DU, Chamiec-Case L, Guy GP. Breast cancer in young women: Health state utility impacts by race/ethnicity. Am J Prev Med 2016; 50(2): 262-9.
  36. Parliament Research Center of the Islamic Republic of Iran. Work Law [Online]. [cited 2019 April 26]. Available from: http://rc.majlis.ir/fa/law/show/99612
  37. National Institute for Health and Care Excellence (NICE). Alemtuzumab for treating highly active relapsing remitting multiple sclerosis [Online]. [cited 2014 May 28]; Available from: URL: https://www.nice.org.uk/guidance/ta312/chapter/3-the-manufacturers-submission
  38. Shingler S, Fordham B, Evans M, Schroeder M, Thompson G, Dewilde S, et al. Utilities for treatment-related adverse events in type 2 diabetes. J Med Econ 2015; 18(1): 45-55.
  39. Iran food and Drug Administration. National Formulary of Iran: Natalizumab [Online]. [cited 2020 Jun 15]. Available from: URL: http://irc.fda.gov.ir/nfi/Detail/15324
  40. Iran Ministry of Health and Medical Education. Tariff of healthcare services in public and private sectors in Iran (2018-2019). Tehran, Iran: Iran Ministry of Health and Medical Education; 2018.
  41. Food and Drug Administration. Mavenclad FDA Label, 2019 (revised) [Online]. [cited 2019 Apr 26]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022561s000lbl.pdf
  42. Orlewska E, Mierzejewski P, Zaborski J, Kruszewska J, Wicha W, Fryze W, et al. A prospective study of the financial costs of multiple sclerosis at different stages of the disease. Eur J Neurol 2005; 12(1): 31-9.
  43. Jick SS, Li L, Falcone GJ, Vassilev ZP, Wallander MA. Mortality of patients with multiple sclerosis: a cohort study in UK primary care. J Neurol 2014; 261(8): 1508-17.
  44. World Health Organization. Life tables by country- Iran (Islamic Republic of) [Online]. [cited 2016]. Available from: http://apps.who.int/gho/data/?theme=main&vid=60760
  45. Djambazov S, Slavchev G, Dineva T, Panayotov P, Vekov T. Cost-effectiveness analysis of cladribine tablets for treatment of patients with relapsing-remitting multiple sclerosis in Bulgaria. Value Health 2018; 21(Suppl 1): S206.
  46. Palace J, Bregenzer T, Tremlett H, Oger J, Zhu F, Boggild M, et al. UK multiple sclerosis risk-sharing scheme: a new natural history dataset and an improved Markov model. BMJ Open 2014; 4(1): e004073.
  47. National Institute for Health and Care Excellence. Cladribine for treating relapsing-remitting multiple sclerosis. Technology appraisal guidance [TA616] [Online]. [cited 2019 Dec 19]; Available from: URL: https://www.nice.org.uk/guidance/ta616
  48. Glennie JL, Torrance GW, Baladi JF, Berka C, Hubbard E, Menon D, et al. The revised Canadian Guidelines for the Economic Evaluation of Pharmaceuticals.
    Pharmacoeconomics 1999; 15(5): 459-68.
  49. National Institute for Health and Care Excellence (NICE). Guide to the Methods of Technology Guide to the Methods of Technology Apprappraisal: Process and Methods [Online]. [cited 2013 Apr 4]; Available from: URL: https://www.nice.org.uk/process/pmg9/resources/guide-to-the-methods-of-technology-appraisal-2013-pdf-2007975843781
Current Journal of Neurology
Volume 20, Issue 3
July 2021
Pages 146-153
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